UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021019 |
|---|---|
| Receipt number | R000023135 |
| Scientific Title | Basic study on development of the silver ion combination bile duct stent |
| Date of disclosure of the study information | 2016/02/14 |
| Last modified on | 2016/02/22 20:08:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Basic study on development of the silver ion combination bile duct stent
Acronym
Study on usefulness of the silver ion stent
Scientific Title
Basic study on development of the silver ion combination bile duct stent
Scientific Title:Acronym
Study on usefulness of the silver ion stent
Region
| Japan |
Condition
Condition
Acute cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inspect the antibacterial action, stent confinement prevention effect of the silver ion stent experimentally
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the bacteria grass which attached inside and outside the stent in the stent which I made silver ion coating on and the stent which I did not give and the bacteria quantity, probe patency degree of the lumen
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient who bile duct, cholecystitis is doubted, and needs treatment with urgent biliary tract drainage 20 years or older.
2) The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation about inspection.
3) Performance status does not have the limit in particular.
Key exclusion criteria
1) Patient 20 years or younger
2) The patient that an agreement about the final examination is not provided
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akane Yamabe |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Gastoroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL
0242-75-2100
akaneko@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akane Yamabe |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL
0242-75-2199
Homepage URL
akaneko@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Without intervention, be the observational studies using samples.
A study period is from May, 2015 to March, 2016.
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023135
